The Hannover Unified Biobank (HUB) – Centralized Standardised Biobanking at Hannover Medical School

Retroviral pre-integration complexes (PICs) provide a most efficient mechanism to integrate foreign DNA into cellular chromatin. This has made retrovirus-based vectors a preferred tool for gene delivery in therapeutic settings where the chromosomal integration of a recombinant expression cassette that encodes a protein of interest can lead to a long-lasting correction of monogenetic diseases (so-called gene addition strategy). However, the efficiency of retroviral gene addition comes at the expense of a lack of precision in the choice of the integration site. Insertional mutagenesis with potential activation of proto-oncogenes as a first hit in a multistep scenario of cancer development thus represents one of the major hurdles to a more widespread exploration of gene-based treatments (Kustikova et al, 2010). To date, four clinical trials were reported to be associated with severe adverse reactions induced by insertional mutagenesis in haematopoietic stem and progenitor cells (HSC/P); two targeting the X-linked form of severe combined immunodeficiency (SCID-X1), one targeting chronic granulomatous disease, and most recently another trial exploring gene therapy for the Wiskott–Aldrich-Syndrome. In contrast, in the SCID caused by mutations in the gene encoding the metabolic enzyme adenosine deaminase (ADA), retroviral gene addition so far has been free of such complications. Furthermore, numerous trials using similar gene vectors to transfer genes into mature T cells have not been complicated by clonal outgrowth. This explains the great interest in a deeper understanding of retroviral vector–host interactions in the therapeutic setting of SCID-ADA.

Since the last World Symposium on Pulmonary Hypertension in 2008, we have witnessed numerous and exciting developments in chronic thromboembolic pulmonary hypertension (CTEPH). Emerging clinical data and advances in technology have led to reinforcing and updated guidance on diagnostic approaches to pulmonary hypertension, guidelines that we hope will lead to better recognition and more timely diagnosis of CTEPH. We have new data on treatment practices across international boundaries as well as long-term outcomes for CTEPH patients treated with or without pulmonary endarterectomy. Furthermore, we have expanded data on alternative treatment options for select CTEPH patients, including data from multiple clinical trials of medical therapy, including 1 recent pivotal trial, and compelling case series of percutaneous pulmonary angioplasty. Lastly, we have garnered more experience, and on a larger international scale, with pulmonary endarterectomy, which is the treatment of choice for operable CTEPH. This report overviews and highlights these important interval developments as deliberated among our task force of CTEPH experts and presented at the 2013 World Symposium on Pulmonary Hypertension in Nice, France.

Fibrinogen is suggested to play an important role in managing major bleeding. However, clinical evidence regarding the effect of fibrinogen concentrate (derived from human plasma) on transfusion is limited. The authors assessed whether fibrinogen concentrate can reduce blood transfusion when given as intraoperative, targeted, first-line hemostatic therapy in bleeding patients undergoing aortic replacement surgery. In this single-center, prospective, placebo-controlled, double-blind study, patients aged 18 yr or older undergoing elective thoracic or thoracoabdominal aortic replacement surgery involving cardiopulmonary bypass were randomized to fibrinogen concentrate or placebo, administered intraoperatively. Study medication was given if patients had clinically relevant coagulopathic bleeding immediately after removal from cardiopulmonary bypass and completion of surgical hemostasis. Dosing was individualized using the fibrin-based thromboelastometry test. If bleeding continued, a standardized transfusion protocol was followed. Twenty-nine patients in the fibrinogen concentrate group and 32 patients in the placebo group were eligible for the efficacy analysis. During the first 24 h after the administration of study medication, patients in the fibrinogen concentrate group received fewer allogeneic blood components than did patients in the placebo group (median, 2 vs. 13 U; P < 0.001; primary endpoint). Total avoidance of transfusion was achieved in 13 (45%) of 29 patients in the fibrinogen concentrate group, whereas 32 (100%) of 32 patients in the placebo group received transfusion (P < 0.001). There was no observed safety concern with using fibrinogen concentrate during aortic surgery. Hemostatic therapy with fibrinogen concentrate in patients undergoing aortic surgery significantly reduced the transfusion of allogeneic blood products. Larger multicenter studies are necessary to confirm the role of fibrinogen concentrate in the management of perioperative bleeding in patients with life-threatening coagulopathy.

a) The advent of precision oncology has led a shift towards biomarker-driven clinical trial designs and molecular profiling of individual patients. Identification of patients with the target biomarker profile may be useful in guiding patient selection as an enrichment strategy for clinical trials. Targeted multiple reaction monitoring mass spectrometry (MRM-MS) analysis for multiplexed quantitation of biomarker proteins in FFPE tissue provides direct, more accurate and precise quantification over current ‘gold standard' immunohistochemistry (IHC) methods. However, MRM-MS has not yet been broadly applied to clinical trials. In this study, we demonstrate the systematic development, optimization and analytical validation of quantitative, multiplexed MRM-MS assays for robust biomarker quantification in clinical FFPE tissues, including sample analysis under GCLP. Results from an MRM panel targeting 8 clinically relevant biomarker proteins will also be shown, including the measured HER2 levels in FFPE breast tumors classified by IHC as 0, 1+, 2+ or 3+. b) MRM-MS biomarker panels were developed and optimized for multiplexed quantitation of ≤12 proteins, in which unique peptides derived from each target protein were monitored as a surrogate measure of protein levels. Tumor regions from FFPE tissue sections were dissected using laser capture or macrodissection, solubilized, digested with trypsin to generate peptides for analysis, spiked with fixed levels of stable isotope labeled (SIL) peptide standards, and analyzed by MRM-MS. Analytical validation was performed per NCI CPTAC guidelines, including response curves, assay repeatability, selectivity, stability, and reproducibility of endogenous detection. Clinical performance was assessed using commercially sourced FFPE-tumor tissues, including a cohort of breast tumor tissues with a wide range of HER2 expression. c) Assay performance results were protein/peptide dependent, with sensitivity in the low pg/μg total protein range. For HER2, assay linearity was demonstrated over 2.5 to 3 orders of magnitude, with a precision and accuracy of &amp;lt;15% over 3 independent runs. In sample analysis, the MRM-MS was sufficiently sensitive to detect HER2 in 1 μg total protein from FFPE breast tumor classified by IHC as negative (0). d) GCLP-compliant quantitative multiplexed large-scale clinical analysis of protein biomarkers by MRM-MS in FFPE tissue is feasible and enables precise and accurate quantitation of proteins when IHC methods are unsuitable or unavailable. Data can be used for patient stratification, optimization of treatment outcomes, drug resistance prediction, and to support clinical development of novel therapies. Citation Format: Maxim Isabelle, Michael Schirm, Gwenael Pottiez, Rudolf Guilbaud, Lorella Di Donato. Clinical proteomics for patient stratification - a GCLP quantitative mass spectrometry workflow for multiplexed measurement of protein biomarkers in FFPE tissues [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr 4163.

Clinical research can be expensive and time consuming due to high associated costs and/or duration of the study. We hypothesized that urine sample collection using online recruitment and engagement of research participants via social medial has the potential to reach a large population in a small timeframe, at a reasonable cost. We performed a retrospective cost analysis of a cohort study comparing cost per sample and time per sample for both online and clinically recruited participants for urine sample collection. During this time, cost data were collected based on study associated costs from invoices and budget spreadsheets. The data were subsequently analyzed using descriptive statistics. Each sample collection kit contained 3 urine cups, 1 for the disease sample and 2 for control samples. Out of the 3,576 (1,192 disease + 2,384 control) total sample cups mailed, 1,254 (695 control) samples were returned. Comparatively, the 2 clinical sites collected 305 samples. Although the initial startup cost of online recruitment was higher, cost per sample for online recruited was found to be $81.45 compared to $398.14 for clinic sample. We conducted a nationwide, contactless, urine sample collection through online recruitment in the midst of the COVID-19 pandemic. Results were compared with the samples collected in the clinical setting. Online recruitment can be utilized to collect urine samples rapidly, efficiently, and at a cost per sample that was 20% of an in-person clinic, and without risk of COVID-19 exposure.

Data in healthcare and routine medical treatment is growing fast. Therefore and because of its variety, possible correlation within these are becoming even more complex. Popular tools for facilitating the daily routine for the clinical researchers are more often based on machine learning (ML) algorithms. Those tools might facilitate data management, data integration or even content classification. Besides commercial functionalities, there are many solutions which are developed by the user himself for his own, specific question of research or task. One of these tasks is described within this work: qualifying the Weber fracture, an ankle joint fracture, from radiological findings with the help of supervised machine learning algorithms. To do so, the findings were firstly processed with common natural language processing (NLP) methods. For the classifying part, we used the bags-of-words-approach to bring together the medical findings on the one hand, and the metadata of the findings on the other hand, and compared several common classifier to have the best results. In order to conduct this study, we used the data and the technology of the Enterprise Clinical Research Data Warehouse (ECRDW) from Hannover Medical School. This paper shows the implementation of machine learning and NLP techniques into the data warehouse integration process in order to provide consolidated, processed and qualified data to be queried for teaching and research purposes.

Urine cytology is a highly effective, straightforward, and cost-efficient diagnostic tool for identifying neoplastic and non-neoplastic changes in the bladder, ureter, and renal pelvis. The aim of this study is to demonstrate the high sensitivity and specificity of urine cytology in detecting a wide range of urothelial lesions, including metastatic involvement. Urine cytology was performed on 9639 cases between 2000 and 2025. The samples, collected from patients, were processed at the Institute of Pathology. Cytological slides were prepared using cytocentrifugation and stained with May-Grünwald-Giemsa (MGG) and Papanicolaou stains. The cytological findings were classified according to WHO, 2004 compared with histological specimens. Additionally, selected cases underwent immunohistochemical and molecular analyses. All samples were anonymized and retrospectively analyzed following the guidelines and regulations of the local ethics committee. Of the total cases, 7051 were classified as benign, 1269 as malignant, and 88 as normal findings. Insufficient material was obtained in 336 cases. No complications were reported during sample collection or processing. The concordance with histological findings for neoplastic lesions was over 96%, with a false-negative rate of 1.84%. The diagnostic methods demonstrated a sensitivity of 90.7% and a specificity of 96.64%. Among the 6956 cases analyzed, 3139 were women (45.13%) and 3817 were men (54.87%). The diagnostic value of urine cytology in representative material is relatively high in assessing both the presence or absence of malignancy and, when applicable, the tumor grade. This large 25-year single-center review demonstrates that urine cytology retains high sensitivity and specificity for the detection of urothelial malignancy, particularly high-grade disease. However, the atypical category remains a major diagnostic challenge and contributes substantially to false-positive results.

Cardiovascular mortality and morbidity in patients with type 2 diabetes following initiation of sodium-glucose

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Benign lesions, inflammation, cysts and pseudocysts, as well as neoplasms of the exocrine and endocrine parts of the pancreas can be easily identified using cytological methods. The sensitivity and specificity can be increased with the help of additional examination methods. The sensitivity of intraoperative rapid cytology reaches about 99%. In the literature, the sensitivity reaches an average of about 85% for biopsies. The method is easy to use, has very low complication rates (1%-2%) and is safe for the patient. 1290 cytological samples from pancreatic lesions were processed in the institute of pathology at Hannover Medical School (MHH), as cytological smears and stained with Giemsa and PAS stains as conventional methods. They were compared with the histological specimens that were processed at the same institute. Immunocytochemistry and molecularpathology have been processed only in selected cases. In general, it is routine in the university that the patients give their written consent to participate in clinical studies. The local ethics committee has stated that there is no need for approval due to the retrospective nature of the study. In this work, we detected 20.077% malignant lesions, 63.333% benign findings and inflammation, 7.441% pseudocysts and cysts. About 9.147% samples were unrepresentative due to insufficient number of cells. This work will highlight the importance of fine aspiration cytology (FNAC) of suspicious pancreatic lesions, its possibilities and limitations in routine diagnostics with discussing the differential diagnoses, pointing to its great value and safety for patients. FNAC is the gold standard, its power is strongly associated with high specificity and sensitivity in the diagnosis of pancreatic lesions, and is very useful in the differential diagnosis between malignant and inflammatory lesions in pancreas.

BackgroundThe advent of precision oncology has led a shift towards biomarker-driven clinical trial designs and molecular profiling of individual patients. Identification of patients with the target biomarker profile may be...

We thank Drs. Yilmaz and Kurt for their comment on our article by Joka et al.1 In that study we evaluated different CK-18 cell death biomarkers for their diagnostic value to differentiate between various fibrosis stages in sera of patients with chronic liver disease (n = 121). We applied the internationally accepted Ishak score for staging of fibrosis.2 Compared to the Metavir score, the Ishak score allows for a more differentiated histopathological assessment, which enables its application not only for chronic viral hepatitis but also for other disease entities. It was not our intention to selectively evaluate the biomarkers in hepatitis C virus (HCV) patients but rather in a broad range of chronic inflammatory liver diseases. As the definition of disease stages, however, does not differ substantially between scores, we would not expect any relevant differences by applying alternative fibrosis scoring systems. Dr. Yilmaz and colleagues found higher levels of M30 in nonalcoholic fatty liver disease (NAFLD) patients with minimal fibrosis compared to those with Wilson's disease and severe fibrosis. In our NAFLD cohort, patients showed no or only minimal fibrosis, which did not influence the diagnostic value of the M30 or M65 assay for prediction of nonalcoholic steatohepatitis (NASH). However, we found that, in contrast to the M65 assays, detection of NASH by the M30 enzyme-linked immunosorbent assay (ELISA) depends on alanine aminotransferase (ALT) levels. Thus, inflammatory disease activity might contribute to higher M30 levels in NAFLD patients despite lower fibrosis stages. In this context, it is also worth mentioning that differences of M30 antigen stability between sera and plasma might contribute to discrepant observations, since concerns about M30 antigen stability in plasma samples during storing have been reported.3 Using serum samples, we did not observe stability issues of the M30 antigen during storing. We certainly agree that NAFLD patients represent a relatively small subgroup in our analysis. However, despite the limited number of NAFL (nonalcoholic fatty liver; n = 10) and NASH (n = 12) patients included, we could demonstrate that, unlike the M30 ELISA, the M65 assays are able to significantly (P < 0.01) distinguish between healthy individuals and patients with NAFL or NASH. This observation is in line with a previous study of NAFLD patients that failed to distinguish between patients with simple steatosis and healthy controls by the M30 assay but demonstrated a higher predictive value of the M65 compared to the M30 assay to identify NASH patients.4 Furthermore, we disagree that the study was substantially underpowered. Boxplot analysis demonstrated a wide overlap for the M30 assay with regard to NAFL and NASH or healthy controls. To be acceptable as a marker for clinical decision making, the discriminatory power of an assay must yield significant results if subgroups of more than 10 patients are studied. In our opinion, one major factor contributing to the lower diagnostic accuracy of the M30 ELISA might be the lower values obtained by the M30 compared to the M65 assays, especially in patients with mild liver diseases. Heike Bantel M.D.*, Matthias J. Bahr M.D. , Jerome Schlue M.D. , Klaus Schulze-Osthoff Ph.D.§, * Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany, Sana Kliniken Luebeck, Luebeck, Germany, Institute of Pathology, Hannover Medical School, Hannover, Germany, § Interfaculty Institute for Biochemistry, University of Tuebingen, Tuebingen, Germany.

Current Opinion in Allergy and Clinical Immunology was launched in 2001. It is one of a successful series of review journals whose unique format is designed to provide a systematic and critical assessment of the literature as presented in the many primary journals. The fields of allergy and clinical immunology are divided into 14 sections that are reviewed once a year. Each section is assigned a Section Editor, a leading authority in the area, who identifies the most important topics at that time. Here we are pleased to introduce the Journal's Section Editors for this issue. SECTION EDITORS Catherine LapriseCatherine LapriseDr Catherine Laprise has been a Professor at the Université du Québec à Chicoutimi (UQAC), Canada, Fundamental Science Department since 2000. She is a member of AllerGen: the Allergy, Genes and Environment Network - a national multidisciplinary research network supporting research, networking, commercialization, knowledge mobilization and capacity building activities that contribute to reducing the morbidity, mortality and socio-economic impact of allergic disease. AllerGen is a member of the Networks of Centres of Excellence (NCE). Dr Laprise is also a member of the scientific committee of the Québec Respiratory Network (QRN) of the Fonds de la recherche en santé du Québec (FRSQ) where she directs the Asthma Strategic Group. She has held a Canada Research Chair on Genetic Determinants in Asthma since January 2005. She is particularly concerned about knowledge transfer and participated in the development and production of several popularization tools on genetics (exhibitions, video, pamphlets, etc.) and was on the administrative committee of the Corporation de Recherche et d’Action sur les Maladies Héréditaires (CORAMH) for 10 years. She is also involved in knowledge transfer through the Committee of the QRN-FRSQ. Her research is mainly focused on the identification of genetic variants in asthma, on gene-gene and gene-environment interactions and on the study of the functions of these genes and their roles in asthma (http://http://www.uqac.ca/genetic/). She has built and manages the French-Canadian Asthma Familial Collection and has conducted several genetic associations (replication and novel associations), which have contributed to documenting the genetics of asthma. Her research helped define the expression profiling of allergic asthma from bronchial tissues and characterizing the functional genetics of some associated genes. The ultimate objective of her research program is to integrate “omics sciences” (genomics, genetics, transcriptomics, epigenetics and proteomics) to better define the molecular nature of asthma, especially allergic asthma, in order to develop personalized diagnostic and therapeutic tools for asthmatic individuals. She also works on several projects pertaining to monogenic diseases such as epidermolysis bullosa simplex and French Canadian type of Leigh syndrome. Emmanuelle BouzigonEmmanuelle BouzigonDr Emmanuelle Bouzigon, M.D., Ph.D., is a researcher at the French National Institute of Health and Medical Research (INSERM), France. She initially attended medical school at Bordeaux University, France, graduating in 2001, as a Medical Doctor in Public Health. She completed her PhD thesis in Genetic Epidemiology at Université Paris-Sud, France, in 2005. She completed a one year research fellowship from the European Network of Excellence Ga2len (Global Allergy and Asthma European Network) in the Department of Genetic Epidemiology, King's College London, UK, where she coordinated a meta-analysis of genome-wide linkage screens for asthma-related phenotypes at the international level. She has been a Research Associate at the INSERM unit of Genetic Variation and Human Diseases in Paris, France, since 2007 and she has been a member of the board of the French Society of Human Genetics (SFGH) since 2008. She has developed a research programme on the genetic determinants of asthma and asthma-associated phenotypes in the french epidemiological study on the Genetics and Environment of Asthma (EGEA) study and European studies, and participates in a number of large scale national and international research groups. Her research interests include the study on gene environment interaction aspects and epigenetic mechanisms. Thomas WerfelThomas WerfelProfessor Werfel is an MD and spent four years as a post-doc in basic immunology before he began his residency at Hannover Medical School, Germany, in the Department of Dermatology. In 1994 he gained Board certification in Dermatology and Allergy and also has a Board membership in Immunology. Since 2008 Professor Werfel has been Head of the Division of Immunodermatology and Allergy Research (Full Professorship) and in addition, the Vice Director of the Department of Dermatology and Allergy at Hannover Medical School. Professor Werfel's research interests focus on chronic inflammatory skin diseases including atopic dermatitis (e.g. role of allergens, microbial antigens and autoantigens in atopic dermatitis, immunology of eczematous skin diseases, new therapeutical approaches in atopic dermatitis). He is currently a member of the Executive Committees of the European Society of Dermatological Research (ESDR), the European Academy of Allergy, Asthma and Clinical Immunology (EAACI) and is Vice President of the Society of Allergy and Clinical Immunology (DGAKI). From 1992 he has continuously received research grants from the “Deutsche Forschungsgemeinschaft” (DFG) and from various research foundations and received several awards for his work in allergy and inflammation research. Torsten ZuberbierTorsten ZuberbierProf. Dr. med. Dr. h. c. Torsten Zuberbier is Managing Director at the Department of Dermatology, Venereology & Allergy, Charité - Universitätsmedizin Berlin, Germany, and holds an honorary doctorate from the University of Athens, Greece. Furthermore, Prof. Zuberbier is the Secretary General of the Global Allergy and Asthma European Network (GA2LEN) - Network of Excellence as well as the spokesperson of the Allergie-Centrum-Charité in the Dermatology Clinic of the Charité in Berlin Mitte. Since 2003 Prof. Zuberbier has been the Head of the European Centre for Allergy Research Foundation (ECARF), Berlin, Germany. His career began in 1990 at the Virchow Clinics, Free University of Berlin, Germany, where in 1995 he became a senior physician at the Dept. of Dermatology. His clinical research focuses on urticaria, atopic eczema, inhalant and food allergies and allergic rhinitis. His research experience is in the domain of human mast cell differentiation and function as well as in clinical allergology with a focus on urticaria, food- and inhalant allergies. He has published more than 300 papers and he is a member of numerous scientific bodies among which: the Editorial Board of the Journal of Clinical and Experimental Dermatology and the Journal der Deutschen Dermatologischen Gesellschaft (JDDG); the advisory board of Allergo Journal; the Executive Committee of the German Society for Allergy and Clinical Immunology; the Expert Commission “Novel Food” of the German Federal Ministry of Consumer Protection, Executive Committee member of ARIA and member of the World Allergy Organisation Communications Council. Prof. Zuberbier was born in 1962 and lives with his family on the outskirts of Berlin, Germany. Leonard BieloryLeonard BieloryDr Bielory attended Lehigh University in Bethlehem, Pennsylvania, USA, where he completed his B.S. in Engineering (Fundamental Science) and a Masters in Molecular Biology (1976); M.D. degree from Rutgers University (previously UMDNJ) - New Jersey Medical School, USA, (1976–1980); internal medicine training at the University of Maryland Hospital, USA; subspecialty training in allergy and immunology and diagnostic laboratory immunology at the National Institutes of Health (NIH), USA, as a medical staff fellow in the – National Heart, Lung and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID) where his research focus has been on the classic immune complex disorder – serum sickness. He was recruited back to his alma mater to direct the Division of Allergy and Immunology at the Rutgers University (previously UMDNJ) - New Jersey Medical School where he has been for 25 years as Professor of Medicine, Pediatrics and Ophthalmology and directed the only training program in Allergy and Immunology in the State of New Jersey for 20 years. He is presently appointed as a Research Professor to the Rutgers University Center of Environmental Prediction. He is consistently selected as one of New Jersey and New York “Top Docs” in the New Jersey and New York metropolitan area surveys for the past 20 years. He has published several hundred publications in peer-reviewed journals, presently serves as an Associate Editor of the Annals of Allergy, Asthma and Immunology, serves on several other editorial boards and as a reviewer for multiple journals. He continues to serve in various capacities in a variety of national organizations including as a member of the Board of Directors for the American College of Allergy, Asthma and Immunology (ACAAI), multiple committee chairs for various committees in the American Academy of Allergy, Asthma and Immunology (AAAAI) and ACAAI, World Allergy Organization, past Chairman of the NIH – National Heart, Lung and Blood Institute Raynaud's Treatment Trial; the program chairman for the ACAAI International Symposium on Complementary Interventions in Treatment of Asthma and Allergy; reviewer for the NIH National Center for Complementary and Alternative Medicine Centers (NCCAM) of Excellence for Research on Complementary and Alternative Medicine (CERC). He has been appointed by the Governor of New Jersey to sit on the Clean Air Council advisory to the New Jersey Department of Environmental Protection and is presently its chair of the recent annual public hearing on Climate Change. Dr Bielory has participated on two United States Pharmacopoeia (USP) Council of Experts Committees (Immunology as well as Respiratory and Allergy). He was an original member of the USP Medicare Model Formulary Committee mandated by the United Stated Congress. He is an international expert in inflammatory disorders of the anterior portion of the eye – especially various forms of ocular allergy and is a regional expert on pollen and climate change. He has successfully completed over 50 clinical research studies in asthma and allergic disorders. Active research focuses on new immune treatments for asthma and a rare disorder known as hereditary angioedema. He has been recently awarded an US Environmental Protection Agency grant as the Principal Investigator focusing on Climate and Allergic Airway Disease that has supported the March 2011 publication in Proceedings of the National Academy of Sciences on Climate Change and Ragweed Pollination with several other publications on climate change under review. Francesca Levi-SchafferFrancesca Levi-SchafferFrancesca Levi-Schaffer is a Professor at The Hebrew University of Jerusalem (HUJI) in the Institute for Drug Research of the School of Pharmacy, Faculty of Medicine, Israel. She holds the Isaac and Myrna Kaye Chair in Immunopharmacology. From 2006–2009 Prof. Levi-Schaffer was Chair of the Department of Pharmacology and Experimental Therapeutics and Head of the Teaching Unit of Pharmacology and Experimental Therapeutics in the HUJI Faculty of Medicine, School of Pharmacy. Prof. Levi-Schaffer was born in Italy and completed her PharmD degree at the University of Milano, Italy. In 1984 she received her PhD degree in Immunology from the Weizmann Institute, Rehovot, Israel. Her post-doctoral training was at Harvard Medical School (1984–86). Prof. Levi-Schaffer has published 153 articles in peer-reviewed journals, 63 reviews and editorials and 23 book chapters. She has one patent and two provisional patents. Prof. Levi-Schaffer is Chairperson of the National Committee of the International Union of Pharmacology (IUPHAR) representing the Israel Academy of Sciences and Humanities and as of 2014 a Councillor of IUPHAR. She established an Immunopharmacology Section in the IUPHAR and serves as its first Chairperson. She is currently a member of the Israeli Ministry of Health Committee for Human Experimentation of New Drugs, the Board of Directors of the World Allergy Organization (WAO), the Management Committee of EU COST Action BM1007 Mast Cells and Basophils and of COST Action BM1201 Developmental Origins of Chronic Lung Disease. In addition, she has been recognized through several international prizes and awards for her scientific activity. Prof. Levi-Schaffer's expertise is in the area of immunopharmacology of allergy. Her research focuses on mast cell and eosinophil cross-talk (AEU) in allergy, mast cells and surface inhibitory and activating receptors; the role of mast cells and eosinophils in hypoxia (allergy, COPD); mastocytosis treatment; autism and allergy; atopic dermatitis and the microbiome; ocular allergy; bispecific antibodies as novel drugs for allergy.

Current Opinion in Allergy and Clinical Immunology was launched in 2001. It is one of a successful series of review journals whose unique format is designed to provide a systematic and critical assessment of the literature as presented in the many primary journals. The fields of allergy and clinical immunology are divided into 14 sections that are reviewed once a year. Each section is assigned a Section Editor, a leading authority in the area, who identifies the most important topics at that time. Here we are pleased to introduce the Journal's Section Editors for this issue. SECTION EDITORS Catherine LapriseCatherine LapriseDr Catherine Laprise has been Professor at the Université du Québec à Chicoutimi (UQAC), Canada, Fundamental Science Department since 2000. She is a member of AllerGen: the Allergy, Genes and Environment Network - a national multidisciplinary research network supporting research, networking, commercialization, knowledge mobilization and capacity building activities that contribute to reducing the morbidity, mortality and socio-economic impact of allergic disease. AllerGen is a member of the Networks of Centres of Excellence (NCE). Dr Laprise is also a member of the scientific committee of the Québec Respiratory Network (QRN) of the Fonds de la recherche en santé du Québec (FRSQ) where she directs the Inflammation and Remodeling Strategic Group. She holds a Canada Research Chair on Genetic Determinants in Asthma and has done since January 2005. She is particularly concerned about knowledge transfer and participated in the development and production of several popularization tools on genetics (exhibitions, video, pamphlets, etc.) and was on the administrative committee of the Corporation de Recherche et d’Action sur les Maladies Héréditaires (CORAMH) for eight years. She is also involved in knowledge transfer through the Committee of the QRN-FRSQ. Her research is mainly focused on the identification of genetic variants in asthma, on gene-gene and gene-environment interactions and on the study of the functions of these genes and their roles in asthma. She has built and manages the French-Canadian Asthma Familial Collection and she has conducted several genetic associations (replication and novel associations) that contributed to documenting the genetics of asthma. Her research helped define the expression profiling of allergic asthma from bronchial tissues and characterizing the functional genetics of some associated genes. The ultimate objective of her research program is to integrate “omics sciences” (genomics, genetics, transcriptomics, epigenetics and proteomics) to better define the molecular nature of asthma, especially allergic asthma, in order to develop personalized diagnostic and therapeutic tools for asthmatic individuals. She also works on several projects pertaining to monogenic diseases such as epidermolysis bullosa simplex and French Canadian type of Leigh syndrome. Emmanuelle BouzigonEmmanuelle BouzigonDr Emmanuelle Bouzigon, M.D., Ph.D., is a researcher at the French National Institute of Health and Medical Research (INSERM), France. She initially attended medical school at Bordeaux University, France, graduating in 2001, as Medical Doctor in Public Health. She completed her PhD thesis in Genetic Epidemiology at Université Paris-Sud in 2005. She completed a one year research fellowship with the European Network of Excellence Ga2len (Global Allergy and Asthma European Network) in the Department of Genetic Epidemiology, King‘s College London, UK, where she coordinated a meta-analysis of genome-wide linkage screens for asthma-related phenotypes at the international level. She has been a Research Associate at the INSERM unit of Genetic Variation and Human Diseases, located at CEPH-Fondation Jean Dausset, Paris, France since 2007 and a member of the board of the French Society of Human Genetics (SFGH) since 2008. She has developed a research programme on the genetic determinants of asthma and asthma-associated phenotypes in the French Epidemiological study on the Genetics and Environment of Asthma (EGEA) study and European studies, and participates in a number of large scale national and international research groups. Her research interests include the study on gene environment interaction aspects and epigenetic mechanisms. Thomas WerfelThomas WerfelProfessor Werfel is an MD and spent four years as a post-doc in basic immunology before he began his residency at Hannover Medical School, Germany, in the Department of Dermatology. In 1994 he gained Board certification in Dermatology and Allergy and also has a Board membership in Immunology. Since 2008 Professor Werfel has been Head of the Division of Immunodermatology and Allergy Research (Full Professorship) and in addition, the Vice Director of the Department of Dermatology and Allergy at Hannover Medical School. Professor Werfel's research interests focus on chronic inflammatory skin diseases including atopic dermatitis (e.g. role of allergens, microbial antigens and autoantigens in atopic dermatitis, immunology of eczematous skin diseases, new therapeutical approaches in atopic dermatitis). He is currently a member of the Executive Committees of the European Society of Dermatological Research (ESDR), the European Academy of Allergy, Asthma and Clinical Immunology (EAACI) and is Vice President of the Society of Allergy and Clinical Immunology (DGAKI). From 1992 he has continuously received research grants from the “Deutsche Forschungsgemeinschaft” (DFG) and from various research foundations and received several awards for his work in allergy and inflammation research. Torsten ZuberbierTorsten ZuberbierProf. Dr. med. Dr. h. c. Torsten Zuberbier is Managing Director at the Department of Dermatology, Venereology & Allergy, Charité - Universitätsmedizin Berlin, Germany, and holds the honorary doctorate from the University of Athens, Greece. Furthermore, Prof. Zuberbier is the Secretary General of the Global Allergy and Asthma European Network (GA2LEN) - Network of Excellence as well as the spokesperson of the Allergie-Centrum-Charité in the Dermatology Clinic of the Charité in Berlin Mitte. Since 2003 Prof. Zuberbier has been the Head of the European Centre for Allergy Research Foundation (ECARF), Berlin, Germany. His career began in 1990 at the Virchow Clinics, Free University of Berlin, Germany, where in 1995 he became a senior physician at the Dept. of Dermatology. His clinical research focuses on urticaria, atopic eczema, inhalant and food allergies and allergic rhinitis. His research experience is in the domain of human mast cell differentiation and function as well as in clinical allergology with a focus on urticaria, food- and inhalant allergies. He has published more than 300 papers and he is a member of numerous scientific bodies among which: the Editorial Board of the Journal of Clinical and Experimental Dermatology and the Journal der Deutschen Dermatologischen Gesellschaft (JDDG); the advisory board of Allergo Journal; the Executive Committee of the German Society for Allergy and Clinical Immunology; the Expert Commission “Novel Food” of the German Federal Ministry of Consumer Protection, Executive Committee member of ARIA and member of the World Allergy Organisation Communications Council. Prof. Zuberbier was born in 1962 and lives with his family on the outskirts of Berlin, Germany. Leonard BieloryLeonard BieloryDr Bielory attended Lehigh University in Bethlehem, Pennsylvania, USA, where he completed his B.S. in Engineering (Fundamental Science) and a Masters in Molecular Biology (1976); M.D. degree from Rutgers University (previously UMDNJ) - New Jersey Medical School, USA, (1976–1980); internal medicine training at the University of Maryland Hospital, USA; subspecialty training in allergy and immunology and diagnostic laboratory immunology at the National Institutes of Health (NIH), USA, as a medical staff fellow in the – National Heart, Lung and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID) where his research focus has been on the classic immune complex disorder – serum sickness. He was recruited back to his alma mater to direct the Division of Allergy and Immunology at the Rutgers University (previously UMDNJ) - New Jersey Medical School where he has been for 25 years as Professor of Medicine, Pediatrics and Ophthalmology and directed the only training program in Allergy and Immunology in the State of New Jersey for 20 years. He is presently appointed as a Research Professor to the Rutgers University Center of Environmental Prediction. He is consistently selected as one of New Jersey and New York “Top Docs” in the New Jersey and New York metropolitan area surveys for the past 20 years. He has published several hundred publications in peer-reviewed journals, presently serves as an Associate Editor of the Annals of Allergy, Asthma and Immunology, serves on several other editorial boards and as a reviewer for multiple journals. He continues to serve in various capacities in a variety of national organizations including as a member of the Board of Directors for the American College of Allergy, Asthma and Immunology (ACAAI), multiple committee chairs for various committees in the American Academy of Allergy, Asthma and Immunology (AAAAI) and ACAAI, World Allergy Organization, past Chairman of the NIH – National Heart, Lung and Blood Institute Raynaud's Treatment Trial; the program chairman for the ACAAI International Symposium on Complementary Interventions in Treatment of Asthma and Allergy; reviewer for the NIH National Center for Complementary and Alternative Medicine Centers (NCCAM) of Excellence for Research on Complementary and Alternative Medicine (CERC). He has been appointed by the Governor of New Jersey to sit on the Clean Air Council advisory to the New Jersey Department of Environmental Protection and is presently its chair of the recent annual public hearing on Climate Change. Dr Bielory has participated on two United States Pharmacopoeia (USP) Council of Experts Committees (Immunology as well as Respiratory and Allergy). He was an original member of the USP Medicare Model Formulary Committee mandated by the United Stated Congress. He is an international expert in inflammatory disorders of the anterior portion of the eye – especially various forms of ocular allergy and is a regional expert on pollen and climate change. He has successfully completed over 50 clinical research studies in asthma and allergic disorders. Active research focuses on new immune treatments for asthma and a rare disorder known as hereditary angioedema. He has been recently awarded an US Environmental Protection Agency grant as the Principal Investigator focusing on Climate and Allergic Airway Disease that has supported the March 2011 publication in Proceedings of the National Academy of Sciences on Climate Change and Ragweed Pollination with several other publications on climate change under review. Stefano BoniniStefano BoniniProfessor Stefano Bonini was born in Rome in 1953. He graduated in 1977, specialized in Ophthalmology in 1981 and Clinical Allergology and Immunology in 1984 at the University of Rome La Sapienza, Italy. During a fellowship of three years at the Eye Research Institute of Boston, Harvard Medical School, USA, he concentrated on the study of ocular immunology and allergology. His primary interest is the study of corneal and conjunctival diseases, particularly regarding inflammatory pathologies. His present position is Professor and Chairman in Ophthalmology and Director of the residents school of Ophthalmology at the University of Rome ‘Campus Bio-Medico’ Italy.

Editorial introductions